GORE TAG Thoracic Endoprosthesis TGT3115Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132613625), received between Nov 8, 2018 and Aug 21, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (1 report).

6 other recalls cover devices cleared under the same FDA submission (P040043); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR TYPE B AORTIC DISSECTION AND IMPENDING RUPTURE OF THORACIC DESCENDING AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESES (TAG). TWO TAGS WERE IMPLANTED SUCCESSFULLY (DISTAL TGT3115, PROXIMAL TGT3720). THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION SHOWED ANEURYSM ENLARGEMENT (ANEURYSMALIZATION) ON THE PROXIMAL AND DISTAL ENDS OF THE TREATMENT AREA OF THE TAGS, RESPECTIVELY. THE ANEURYSM OF THE DISTAL SIDE WAS ESPECIALLY LARGE AND AN ADDITIONAL TREATMENT WAS INDICATED. ON (B)(6) 2024, AN ADDITIONAL STENT GRAFT WAS PLACED TO THE DISTAL OF THE PREVIOUS TAGS. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE CONTRAST-ENHANCED CT SHOWED HETEROGENEOUS CONTRAST EFFECT OF THE ANEURYSM, WHICH MAY HAVE INDICATE INFECTION, INFLAMMATION, OR TUMOR. MOST LIKELY, IT WAS TUMOR INVASION BECAUSE THE BLOOD TEST WAS NEGATIVE FOR INFLAMMATION, THE PATIENT WAS TREATED FOR LUNG CANCER AT ANOTHER HOSPITAL, AND THE PET-CT PERFORMED AT ANOTHER HOSPITAL SHOWED FDG ACCUMULATION. THE PATIENT WAS RECEIVING TREATMENT WITH KEYTRUDA AND EXPECTED TO HAVE A CERTA

  Patient problems: Aneurysm expansion

  MAUDE report 20015383 ↗
• InjurySep 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AORTIC DISSECTION USING A GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED AS A DISTAL STENT GRAFT-INDUCED NEW ENTRY TEAR (D-SINE) WAS FOUND BY A FOLLOW-UP CT SCAN. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADDITIONALLY IMPLANTED TO EXTEND THE TREATMENT AREA DISTALLY FOR APPROXIMATELY 3 CM. NO ENDOLEAK WAS FOUND. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE DISTAL FLARE OF THE DEVICE PROBABLY CAUSED THE D-SINE.

  Patient problems: Vascular Dissection

  MAUDE report 17760778 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE. ON UNKNOWN DATE, TOTAL ARCH REPLACEMENT WAS PERFORMED USING A SURGICAL GRAFT. ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT OF THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (PROXIMAL-TGT3115/9042283, DISTAL-TGT3420/9077511). THE PROXIMAL END OF THE TGT3115 WAS PLACED IN THE DISTAL ANASTOMOSIS OF THE SURGICAL GRAFT. THE PROCEDURE WAS FINISHED WITH NO EVIDENCE OF ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, IT WAS CONFIRMED THAT THE TGT3115 MIGRATED DISTALLY. THERE WAS AN UNKNOWN LEAK BETWEEN THE DISTAL ANASTOMOSIS AND THE TGT3115. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN ORDER TO DETERMINE THE ORIGIN OF THE LEAK, BUT IT WAS UNABLE TO DETERMINE THE EXACT ORIGIN OF THE LEAK. THE PHYSICIAN REPORTEDLY STATED THAT THE EXACT CAUSE OF THE LEAK WAS UNKNOWN. THE FLARE (THE PROXIMAL END) OF THE TGT3115 MIGHT HAVE CAUSED A DAMAGE TO THE SURGICAL GRAFT AND IT RESULTED IN A LEAK FROM THE SURGICAL GRAFT. ON (B)(6) 2018, THE PATIENT UNDERWENT SECONDARY INTERVENTION FOR TREATMENT OF UNKNOWN LEAK. A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS (TGU343420J) WAS IMPLANTED COVERING THE DISTAL ANASTOMOSIS OF THE

  Patient problems: Aneurysm expansion

  MAUDE report 17105076 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2022, THE PATIENT HAD BACK PAIN AND WAS TAKEN TO THE HOSPITAL. A PSEUDOANEURYSM WAS OBSERVED AT THE DISTAL SIDE EDGE OF THE DEVICE. AN EMERGENT TEVAR TOOK PLACE, AN ADDITIONAL STENT GRAFT WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT SPRING BACK FORCE DURING THE INITIAL DEPLOYMENT PROCEDURE MIGHT HAVE STRESSED THE AORTA OF THE DISTAL SIDE OF THE DEVICE, WHICH MIGHT HAVE LED TO THE PSEUDOANEURYSM.

  Patient problems: Pseudoaneurysm

  MAUDE report 14632616 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A TOTAL AORTIC ARCH REPLACEMENT USING FROZEN ELEPHANT TRUNK TECHNIQUE TO TREAT A TYPE A AORTIC DISSECTION. ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® TAG® THORACIC ENDOPROSTHESES (TAG). THE TAG DEVICE WAS IMPLANTED DISTALLY OF THE ELEPHANT TRUNK. THE REASON FOR THIS PROCEDURE IS THAT THE ELEPHANT TRUNK WAS THINNER THAN THE AORTA, AND COULD NOT GET ENOUGH SEALING; HENCE, THE TAG DEVICE WAS ADDITIONALLY PLACED. ON AN UNKNOWN DATE IN 2021, FALSE LUMEN EXPANSION OF UNKNOWN AMOUNT WAS OBSERVED. AND A TYPE III ENDOLEAK (COMPONENT DISCONNECTION) WAS SUSPECTED. REPORTEDLY, THE LENGTH OF COMPONENT OVERLAPPING WAS APPROXIMATELY 2 TO 3 CM ON (B)(6) 2021, A REINTERVENTION TOOK PLACE WHEREBY AN ADDITIONAL STENT GRAFT WAS IMPLANTED DISTAL THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 12821577 ↗
• InjuryAug 17, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ON (B)(6) 2013, A PATIENT UNDERWENT SURGICAL REPAIR OF A THORACIC AORTIC ANEURYSM WITH ARCH REPLACEMENT AND AN ELEPHANT TRUNK PROCEDURE, AND THEN ENDOVASCULAR TREATMENT FROM THE ELEPHANT TRUNK TO THE DESCENDING AORTA USING TWO GORE® TAG® THORACIC ENDOPROSTHESES. A 31MM GORE® TAG® DEVICE WAS IMPLANTED PROXIMALLY, AND A 34MM GORE® TAG® DEVICE WAS IMPLANTED DISTALLY. ON UNKNOWN DATE, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REPORTEDLY REVEALED ANEURYSM ENLARGEMENT (AMOUNT NOT REPORTED), AND A SUSPECTED TYPE IA OR TYPE II ENDOLEAK AT THE PROXIMAL SEND OF THE ANEURYSM. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED. AN ANGIOGRAPH PRIOR TO THE PROCEDURE REPORTEDLY SHOWED NO SIGNIFICANT ENDOLEAK. HOWEVER, THE PHYSICIAN SUSPECTED A SLIGHT PROXIMAL TYPE I ENDOLEAK FROM BETWEEN THE ELEPHANT TRUNK AND THE PROXIMAL GORE® TAG® DEVICE DUE TO A GAP OR INSUFFICIENT OVERLAP LENGTH. AN ADDITIONAL 31MM GORE® TAG® DEVICE WAS IMPLANTED TO EXTEND TO THE PROXIMAL SIDE. A FINAL PROCEDURAL ANGIOGRAPH REVEALED NO ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12334045 ↗
• InjuryJan 28, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESES (TAG). ON (B)(6) 2021, THE PATIENT EXPRESSED BEING IN PAIN. A CT IMAGING REVEALED A DISTAL TYPE I ENDOLEAK, ANEURYSM ENLARGEMENT, AND DISTAL MIGRATION OF THE TAG WAS ALSO SUSPECTED. AN EMERGENT REINTERVENTION TOOK PLACE WHEREBY AN ADDITIONAL STENT GRAFT WAS PLACED AT THE DISTAL END OF THE TAG DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11247651 ↗
• InjuryDec 15, 2020Misconnection; Misconnection

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION USING GORE® TAG® THORACIC ENDOPROSTHESES. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION REPORTEDLY REVEALED A DISTAL STENT GRAFT INDUCED NEW ENTRY (DSINE), AND FALSE LUMEN EXPANSION. ON (B)(6) 2020 A RE-INTERVENTION PROCEDURE WAS PERFORMED WHEREBY A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED TO TREAT THE DSINE. THE PATIENT TOLERATED THE PROCEDURE. (ABOVE EVENT INFORMATION HAS BEEN CAPTURED IN PREVIOUS MFR REPORT # 2017233-2020-01003) ON AN UNKNOWN DATE, FOLLOW-UP IMAGING REPORTEDLY IDENTIFIED FALSE LUMEN EXPANSION, AND A TYPE III ENDOLEAK (COMPONENT DISCONNECTION) WAS SUSPECTED. THE PHYSICIAN COMMENTED THAT A LACK OF SUFFICIENT OVERLAP BETWEEN THE TWO DISTAL GORE® TAG® DEVICES MAY HAVE CONTRIBUTED TO THIS OBSERVATION. ON (B)(6) 2020, A RE-INTERVENTION WAS PERFORMED WHEREBY AN ADDITIONAL GORE® TAG® DEVICE WAS IMPLANTED TO RELINE THE PREVIOUSLY PLACED STENT GRAFTS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT A TYPE II ENDOLEAK WAS ALSO OBSERVED ON A FINAL PROCEDURAL ANGIOGRAPH, BUT THE PHYSICIAN ELECTED TO MONITOR IT AND NO FURTHER

  Patient problems: No Code Available

  MAUDE report 11013235 ↗
• InjuryJun 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION USING GORE® TAG® THORACIC ENDOPROSTHESES. ON AN UNKNOWN DATE, THE FOLLOW UP IMAGING REVEALED A DISTAL STENT GRAFT INDUCED NEW ENTRY (DSINE), AND FALSE LUMEN EXPANSION. ON (B)(6) 2020 A REINTERVENTION WAS PERFORMED WHEREBY A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED TO TREAT THE DSINE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aortic Dissection

  MAUDE report 10171950 ↗
• InjuryNov 8, 2018Migration; Migration

  ON UNKNOWN DATE, TOTAL ARCH REPLACEMENT WAS PERFORMED USING A SURGICAL GRAFT. ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM WITH TWO GORE® TAG® THORACIC ENDOPROSTHESES (PROXIMAL-TGT3115, DISTAL-TGT3420). THE PROXIMAL END OF THE TGT3115 WAS PLACED IN THE DISTAL ANASTOMOSIS OF THE SURGICAL GRAFT. THE PROCEDURE WAS FINISHED WITH NO EVIDENCE OF ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, IT WAS IDENTIFIED THAT THE TGT3115 WAS MIGRATED DISTALLY. THERE WAS AN UNKNOWN LEAK BETWEEN THE DISTAL ANASTOMOSIS AND THE TGT3115. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN ORDER TO DETERMINE THE ORIGIN OF THE LEAK, BUT IT WAS NOT ABLE TO DETERMINE THE EXACT ORIGIN OF THE LEAK.THE PHYSICIAN REPORTEDLY STATED THAT THE EXACT CAUSE OF THE LEAK WAS UNKNOWN. THE FLARE (THE PROXIMAL END) OF THE TGT3115 MIGHT HAVE CAUSED A DAMAGE TO THE SURGICAL GRAFT AND IT RESULTED IN A LEAK FROM THE SURGICAL GRAFT. ON (B)(6) 2018, THE PATIENT UNDERWENT SECONDARY INTERVENTION TO TREAT THE UNKNOWN LEAK. A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS (B)(4) WAS IMPLANTED COVERING THE DISTAL ANASTOMOSIS OF THE SURGICAL GRAFT AND THE PROXIMAL END OF THE TGT3115. A

  Patient problems: Aneurysm

  MAUDE report 8053259 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040043. One submission often covers many models, so check the product and lot details in each record.

• Z-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-2052-2020 · Dec 17, 2019 · Terminated
  Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
• Z-0048-2018 · Sep 25, 2017 · Terminated
  GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm